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FDA issues warning letter to Smith & Nephew for German facility

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The FDA has issued a warning letter to Smith & Nephew PLC’s London office relating to inspections at the company’s Tuttlingen, Germany facility which produces the R3 Ceramic Acetabular System.

The letter lists five quality-control related violations which were reported last July to the manufacturer, which the agency feels were not adequately addressed in the company’s subsequent response.

“This issue was first raised in July and Smith & Nephew is working with the FDA to correct the issue,” a company spokesperson told ORTHOSuperSite.com. “Remedial action has been taken. However, the FDA is not currently satisfied with [what has been done].

“We will be working with the FDA to correct the issue,” he said.

The FDA has given Smith & Nephew 15 days from Dec. 21 to respond with steps the company will be taking to correct the violations.

Smith & Nephew said that the R3 Ceramic Acetabular systems are also manufactured in Warwick in the United Kingdom and Memphis, Tenn. and there are no issues in terms of supply to customers.

“Also, there have been no patient events related to the issue,” the spokesperson said.